【作者】 王瓅珏； 吴明凤； 王丹蕾； 范华莹； 谢振伟； 苏明； 郭丹杰； 张华； 王天兵； 王豪；

【Author】 WANG Lijue;WU Mingfeng;WANG Danlei;FAN Huaying;XIE Zhenwei;SU Ming;GUO Danjie;ZHANG Hua;WANG Tianbing;WANG Hao;Peking University People’s Hospital, Science and Research Department;

【机构】 北京大学人民医院科研处；

【摘要】 根据国务院和科技部要求,药物临床试验中凡涉及采集、收集、买卖和出口出境人类遗传资源信息时,均需在获得人类遗传资源管理办公室的行政审批后方可执行。本文对我院药物临床试验机构在审核人类遗传资源申请书过程中的常见问题进行了分析,并提出了应对的解决措施。这些问题也是今后审核人类遗传资源申请书时的要点,包括样本的采集收集计划与试验方案一致性、伦理审查与知情同意书规范性、知识产权归属合规性等。更多还原

【Abstract】 According to the requirements of the State Council and the Ministry of Science and Technology, all information related to the collection, trade and export of human genetic resources in drug clinical trials is subject to the administrative approval of the Human Genetic Resources Management Office. This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institutions in our hospital, and proposes solutions to the problems. These issues are also the main points in the future review of human genetic resources applications, including the collection of sample and consistency with clinical trial plan, ethical review and informed consent, intellectual property rights etc.更多还原